Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.
Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.
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DOI：
10.1016/j.jaci.2009.05.041
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发表时间：
2009-09
影响因子：
14.2
通讯作者：
Sugar, Elizabeth A.
中科院分区：
文献类型：
--
作者：
Wise, Robert A.;Bartlett, Susan J.;Brown, Ellen D.;Castro, Mario;Cohen, Rubin;Holbrook, Janet T.;Irvin, Charles G.;Rand, Cynthia S.;Sockrider, Marianna M.;Sugar, Elizabeth A.
提高药物有效性预期的信息可以改善对安慰剂疼痛的反应。尽管哮喘通常在安慰剂治疗后得到改善，但目前尚不清楚是否可以通过增加获益预期来增强对安慰剂或活性治疗的反应。研究的目的是确定对安慰剂或白三烯拮抗剂（孟鲁司特）的反应是否可以通过增加获益预期的信息来增强。一项20个中心的随机对照试验纳入了601名症状控制不佳的哮喘患者，他们被分配到五个研究组之一。参与者被随机分配到析因设计的四个治疗组：安慰剂与增强信息，安慰剂与中性信息，孟鲁司特与增强信息，或孟鲁司特与中性信息;或常规护理。研究药物分配为双盲;消息内容分配为单盲;常规治疗未设盲。增强的信息旨在增加对药物获益的预期。主要结果是4周内每日峰值流量的平均变化。次要结局包括肺功能和哮喘症状控制。对于孟鲁司特或安慰剂，分配到增强信息组与中性信息组的参与者的峰值流量和其他肺功能指标没有改善;中性安慰剂组与常规护理组之间没有差异。安慰剂治疗的受试者通过增强的信息改善了哮喘控制，但孟鲁司特治疗的受试者没有改善;在校正基线差异后，与常规治疗相比，中性安慰剂确实改善了哮喘控制。头痛在提供孟鲁司特副作用头痛信息的参与者中更常见。乐观的药物呈现增加了患者报告结果（哮喘控制）的安慰剂效应，但不是肺功能。然而，孟鲁司特的效果并没有因为关于治疗有效性的乐观信息而增强。
Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma often improves with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. The study objective was to determine if response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. A randomized 20-center controlled trial enrolled 601 asthmatics with poor symptom control were assigned to one of five study groups. Participants were randomly assigned to either four treatment groups in a factorial design: placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages; or to usual care. Assignment to study drug was double-masked; assignment to message content was single-masked; usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak-flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus neutral messages groups for either montelukast or placebo; no differences were noted between neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message, but not montelukast-treated participants; neutral placebo did have improved asthma control compared to usual care after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control), but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.
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影响因子：
64.8
作者：
LEVINE, JD;GORDON, NC
通讯作者：
GORDON, NC
影响因子：
4.3
作者：
Juniper, EF;Bousquet, J;Bateman, ED
通讯作者：
Bateman, ED
影响因子：
7.4
作者：
De Pascalis, V;Chiaradia, C;Carotenuto, E
通讯作者：
Carotenuto, E
影响因子：
1.8
作者：
Brodwater, BK;Major, NM;Layfield, LJ
通讯作者：
Layfield, LJ
影响因子：
--
作者：
deCraen, AJM;Roos, PJ;Kleijnen, J
通讯作者：
Kleijnen, J